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Attentional Bias Modification in Patients With Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborators:
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
PsyQ
ClinicalTrials.gov Identifier:
NCT00764101
First received: September 29, 2008
Last updated: July 7, 2011
Last verified: July 2011
History of Changes
  Purpose

Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.


Condition Intervention Phase
Posttraumatic Stress Disorder
 Behavioral: Attentional Bias Modification
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Attentional Bias Modification on Attentional Bias and Symptoms of Posttraumatic Stress Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PsyQ:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: End of Trial + 3 week Follow-Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD symptoms (self-report) [ Time Frame: end of trial + 3wk Follow Up ] [ Designated as safety issue: No ]
  • Attentional Bias (dot-probe test) [ Time Frame: End of trial + 3wk Follow-up ] [ Designated as safety issue: No ]
  • Emotional Stroop Interference [ Time Frame: End of trial + 3wk Follow Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
9 sessions of attentional bias modification (computerized training program)
 Behavioral: Attentional Bias Modification
computerized training to reduce attentional bias in posttraumatic stress disorder
Other Name: Attentional Training
Placebo Comparator: 2
Attentional control condition (placebo training program)
 Behavioral: Attentional Bias Modification
computerized training to reduce attentional bias in posttraumatic stress disorder
Other Name: Attentional Training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Posttraumatic Stress Disorder

Exclusion Criteria:

  • Diagnosis of psychosis, drug- or alcohol dependency/abuse;
  • Unable to fill in questionnaires in Dutch;
  • Color blindness (Stroop test).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764101

Locations
Netherlands
PsyQ Haaglanden, department of psychotrauma
Den Haag, Zuid Holland, Netherlands, 2593 HR
Sponsors and Collaborators
PsyQ
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Willem van der Does, professor Leiden University Medical Center
Principal Investigator: Maartje Schoorl, MS PsyQ Nederland bv
  More Information

No publications provided by PsyQ

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Willem Van der Does, PhD, Leiden University
ClinicalTrials.gov Identifier: NCT00764101     History of Changes
Other Study ID Numbers: 60-60105-98-128
Study First Received: September 29, 2008
Last Updated: July 7, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013